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The Arteriovenous Vascular (AV) ACCESS Trial

About

Brief Summary

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
65 Years
Maximum Age
N/A

Inclusion Criteria:

  • Age 65 years or older
  • End-stage kidney disease on hemodialysis via a central venous catheter
  • Hemodialysis is the long-term modality of treatment for end-stage kidney disease
  • Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
  • Referred by patient's nephrologist for placement of arteriovenous access
  • At least one of the following comorbid conditions: coronary artery disease, peripheral arterial disease, and/or diabetes mellitus
  • Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
  • Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
  • Patient agreed to study participation and signed the informed consent

Exclusion Criteria:

  • Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
  • Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
  • Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
  • Anticipated kidney transplant within 12 months
  • Anticipated conversion to peritoneal dialysis within 12 months
  • Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
  • Anticipated non-compliance with medical care based on physician judgment

Join this Trial

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Study Stats
Protocol No.
22-000180
Category
Surgery
Contact
Nakeisha Favors
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04646226
For detailed technical eligibility, visit ClinicalTrials.gov.